An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Bisacodyl

Criteria

Inclusion Criteria:

• Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

• At least 18 years of age

• Otherwise in good health, as determined by physical exam and medical history

• If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)

• Negative urine pregnancy test at screening, if applicable

• In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

• Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon

• Subjects with impaired consciousness that predisposes them to pulmonary aspiration

• Subjects who are undergoing colonoscopy for foreign body removal and decompression

• Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics

• Subjects who are taking drugs that may affect electrolyte levels

• Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study

• Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia

• Subjects who are pregnant or lactating, or intending to become pregnant during the study

• Subjects of childbearing potential who refuse a pregnancy test

• Subjects who are allergic to any preparation components

• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures

• Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days